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Clinical Trials/NCT05640492
NCT05640492
Recruiting
Not Applicable

Metacognitive Training in the Older Adults With Depressive Symptoms

University of Évora1 site in 1 country120 target enrollmentJanuary 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Évora
Enrollment
120
Locations
1
Primary Endpoint
Hamilton Depression Rating Scale (HRSD-24)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Depression is one of the most common mental disorders in older adults and a major cause of years lived with disability. Depression does not always respond to antidepressants, and non-pharmacological interventions are recommended by international guidelines. The Metacognitive Training for Depression in Later Life (MCT-Silver) is a creative and innovative group intervention that aims to reduce depressive symptoms by challenging the cognitive and metacognitive beliefs characteristic of this disorder, that intends to enable participants to recognize and correct their automatic and dysfunctional thinking patterns and behavior. It was developed by the partner institution's team, and has already demonstrated positive results. This project aims to extend the research study to Portugal, through cultural adaptation, pilot study, and a Randomized Controlled Trial (RCT). To this end, we defined the following aims: To plan and conduct a pilot study to assess the efficacy of the MCT-Silver in the Portuguese population; To conduct a multicenter randomized controlled trial (RCT).

Registry
clinicaltrials.gov
Start Date
January 5, 2023
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Évora
Responsible Party
Principal Investigator
Principal Investigator

Lara Manuela Guedes de Pinho

Principal Investigator

University of Évora

Eligibility Criteria

Inclusion Criteria

  • Ability to give informed consent
  • Age: 60 years or older
  • Sufficient command of the Portuguese language
  • Willingness to participate in the intervention for a period of 4 to 8 weeks (participants who do not participate in the intervention will also be included in the analysis)
  • Adequate visual and hearing acuity for neuropsychological testing and participation in the group sessions
  • Values above 10 on the Hamilton Depression Scale

Exclusion Criteria

  • Active psychotic symptoms (i.e., hallucinations, delusions, or manias)
  • Acute suicidal ideation
  • Cognitive impairment
  • Dementia or other neurological disease

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale (HRSD-24)

Time Frame: Follow-up (6 months after the intervention)

The 24-item version of the Hamilton Depression Rating Scale is an established clinician-

Secondary Outcomes

  • Dysfunctional Attitudes Scale Form 18B (DAS-18B)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Beck-Depressions-Inventar II (BDI-II)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Mini Mental State Examination (MMSE)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Attitudes to Ageing Questionnaire (AAQ)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Ruminative Responses Scale(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • World Health Organization Quality of Life-BREF - Item 1(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Patient Health Questionnaire 9 (PHQ-9)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Metacognitions Questionnaire (MCQ-30)(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • ICF Core Set for Depression(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])
  • Rosenberg Self-Esteem Scale(Total Time Frame is 7 months. Outcome is assessed at three points: baseline; post-intervention and Follow-up (6 months after the intervention)])

Study Sites (1)

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